跳至主要内容
临床试验/NCT04848766
NCT04848766Unknown不适用

Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
9,000
试验地点
1
主要终点
Net adverse clinical and cerebral events (NACCE)

研究概览

简要总结

We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.

详细描述

This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published.

We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include "acute coronary syndrome", "ACS", "primary", "percutaneous coronary intervention", "PCI", "de-escalation", "guided", "guide", "antiplatelet", "P2Y12 inhibitor", "P2Y12", "dual antiplatelet therapy", "DAPT".

Articles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.

After selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject must have clinical diagnosis of acute coronary syndrome

排除标准

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor

研究组 & 干预措施

De-escalation treatment group

Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention

干预措施: De-escalation Treatment Strategy of dual antiplatelet therapy (Drug)

结局指标

主要结局

Net adverse clinical and cerebral events (NACCE)

时间窗: 1 year after intervention

composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.

次要结局

  • Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria(1 year after intervention)
  • Individual components of the primary outcome(1 year after intervention)
  • Composite endpoint of Major adverse cardiovascular outcomes(1 year after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Soo Kim

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

IPD Meta-analysis of De-escalation Treatment... | 临床试验